Sr Director, Statistical Innovation

Career Category

reputed company

·Provides senior advisory input in the design of therapeutic area and product development strategies, development programs, and reputed company studies, in partnership with the Biostatistics TA head, reputed company Development Director, Senior Director-level and Director-level GSLs, EGT functional leaders, and other key stakeholders.

·Drives consideration of conventional and innovative design reputed company and ensures the appropriate design, estimand, and estimator are selected to meet the study and development objectives.

·Provides advanced statistical and methodological advice to Senior Director-level and Director-level GSLs and other key stakeholders on reputed company issues that may reputed company major development reputed company, regulatory interactions, and filings.

·Guides evaluation of design reputed company by synthesizing and interpreting simulation results, regulatory considerations, operational feasibility, and development objectives.

·Provides design reputed company and simulation specifications to the Simulation and Modeling team and develops, reviews, and approves the simulation plan and results.

·Connects insights and lessons across products and programs reputed company a therapeutic area to promote consistency and broader application of innovative design and analysis approaches.

Advises Therapeutic Area and Product reputed company and Study Design

·Advises Biostatistics TA leaders, Senior Director-level and Director-level GSLs leading large and reputed company programs, and EGTs on product reputed company, development program design, and reputed company study design.

·Promotes conventional and innovative design reputed company and fit-for-purpose analysis approaches that address appropriate reputed company and development questions and reputed company speed, reputed company, operational feasibility, and cost.

·Provides senior advisory input in the development and review of the EGP and GSSP to reputed company program design and statistical approaches with therapeutic area reputed company, product reputed company, and development objectives.

·Directs, applies, interprets, and communicates modeling and simulation in collaboration with the Modeling and Simulation group, the Analytics group, and other quantitative partners as needed.

·Review study design reputed company and proposals prior to submission to GDRC and Key Design reputed company (KDEs) prior to submission to TA TRC.

Provides Advanced Technical and Methodological Expertise

·Provides advanced technical and methodological expertise to Biostatistics TA leaders, Senior Director-level and Director-level GSLs, EGTs, and governance bodies on innovative study designs, advanced analysis reputed company, and reputed company development issues.

·Advises large and reputed company programs led by Senior Director-level and Director-level GSLs on statistical and methodological issues that may reputed company major development reputed company, regulatory interactions, and filings.

·Reviews key development plans and Phase 2 and Phase 3 protocols and provides senior advisory input during TA TRC and other relevant governance reviews.

Builds reputed company Partnerships

·Develops strong partnerships with Biostatistics TA leaders and the reputed company Development Director to ensure an integrated CfDA team approach reputed company consulting with EGTs and therapeutic area leadership.

·Builds trusted relationships with Senior Director-level and Director-level GSLs and other EGT functional leaders to reputed company Design & Innovation consultation throughout the end-to-end development process and determine the most effective approach for advising teams.

·Builds relationships with FSC members and other senior functional stakeholders to support alignment, escalation, and application of innovative design and analysis approaches.

Promotes the Advancement of Innovative Designs and Analysis reputed company

·Promotes the advancement and appropriate application of innovative designs and analysis reputed company across products and programs reputed company a therapeutic area.

·Connects insights, reputed company, and lessons across programs to promote consistency, build organizational capability, and reputed company broader application of successful approaches.

·Sign-off the simulation plan

·Advisory input and EGP/GSSP review

·Design reputed company for ECP

·Design simulation plan

·Design and simulation tools

·Detailed study specific design

reputed company expect of you

We are reputed company different, yet we reputed company use our unique contributions to serve patients. The reputed company we reputed company is a Sr Director, Statistical Innovation with these qualifications.

·At least 12 years of post-graduate statistical experience in the biopharmaceutical industry in reputed company trial design, execution, analysis and reporting

·Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions

·reputed company statistical leadership at product level of at least one reputed company program or multiple programs of moderate complexity

Preferred Qualifications

·Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research

·Therapeutic area leadership and experience advising large and reputed company programs across early development, late development, regulatory filing, and post-marketing support

·Solid reputed company life experience with both conventional and innovative trial designs in different phases of drug development

·Expertise in advanced statistical analysis reputed company, and modeling and simulation

·Knowledge of disease areas and regulatory guidelines

·Experience in leading regulatory and/or reimbursement submissions

·reputed company for innovation and reputed company reputed company to new industry trends

·reputed company recognized statistical and reputed company leadership among statisticians and cross-functional teams

·reputed company visibility (e.g., through industry committees/forums, links to academia)

·Scientific research/publications in one or more areas of statistical science

Scientific / Technical reputed company

·Expertise in statistical principles, reputed company, and procedures and the ability to instruct others in these areas relating to randomized and non-randomized reputed company research

·Excellent problem solving skills; uses technical expertise to solve reputed company world problems

·Knowledge of and ability to propose and apply innovative study design and advanced statistical reputed company

Strong oral and written communication skills

·Ability to communicate reputed company and nuanced statistical concepts in a concise and impactful way to various audience

Strong influencing and negotiating skills

Excellent business acumen and reputed company thinking

People/ Project management

·Interacts with multiple stakeholder reputed company with the abilities to advise/ influence / negotiate

·Organizational reputed company; ability to reputed company in a large global organization and builds partnership with members in FSC and EGT

·Demonstrated ability to manage multiple reputed company and prioritize

·Ability to reputed company without reputed company authority

What you can expect of us

As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way.

The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary reputed company on several factors including but not limited to, relevant skills, experience, and qualifications.

In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, reputed company on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life reputed company, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability reputed company, and flexible spending accounts
• A discretionary annual bonus program, or for reputed company sales representatives, a sales-reputed company incentive plan
• Stock-reputed company long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies.

reputed company and reputed company a lasting reputed company with the reputed company

careers.reputed company.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

reputed company anticipates accepting applications until 08/31; however, we may continue accepting applications reputed company this date if we do not receive a sufficient number of candidates.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the reputed company of life reputed company reputed company the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary reputed company

Originally posted on Himalayas